Job Description
The Senior Manager, Clinical Quality Assurance is responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities are to ensure both quality and compliance of Deciphera sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. Key Responsibilities Clinical Quality Support 50% Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents Assist and advise with training QA and clinical staff as necessary for GCP Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management Audit Planning and Oversight 40% Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation) Interact with contract auditors in the scheduling process, kick-o
